Cytovance Biologics vs FUJIFILM Diosynth Biotechnologies: CDMO Comparison

How does Cytovance Biologics compare to FUJIFILM Diosynth Biotechnologies for Biologics manufacturing?

Side-by-side comparison of Cytovance Biologics and FUJIFILM Diosynth Biotechnologies on independent FDA inspections, EMA and MHRA GMP certificates, clinical-program activity, and CDMO Signal Score. Data sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

Oklahoma City, OK
Signal Score
79/100
Quality (FDA + GMP)
98/100
FDA inspections
1
— NAI / VAI / OAI
0 / 1 / 0
FDA warning letters
0
EMA GMP certificates (active)
0
MHRA GMP certificates (compliant)
0
Clinical programs (matched)
0
Capacity
Available
Modalities
Microbial Fermentation, Biologics, Recombinant Proteins, Mammalian Cell Culture, Plasmid DNA
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
Signal Score
85/100
Quality (FDA + GMP)
100/100
FDA inspections
0
FDA warning letters
0
EMA GMP certificates (active)
29
MHRA GMP certificates (compliant)
6
Clinical programs (matched)
0
Capacity
Expanding
Modalities
AAV, mRNA/LNP, Biologics, mRNA, Microbial Fermentation, Recombinant Protein

Key differences

  • Cytovance Biologics has FDA inspections on record (1); FUJIFILM Diosynth Biotechnologies does not yet appear in the FDA inspection database.
  • Both maintain clean enforcement records — no FDA OAI classifications or warning letters on file for either CDMO.
  • FUJIFILM Diosynth Biotechnologies holds 29 active EMA GMP certificates; Cytovance Biologics does not appear in EudraGMDP.
  • FUJIFILM Diosynth Biotechnologies maintains 6 MHRA / UK GMP certificates; Cytovance Biologics does not.

On a 13-modality CDMO landscape, both Cytovance Biologics and FUJIFILM Diosynth Biotechnologies qualify as Biologics manufacturers; FUJIFILM Diosynth Biotechnologies carries the higher composite Signal Score for Biologics programs in this comparison.

What to evaluate for Biologics programs

Both Cytovance Biologics and FUJIFILM Diosynth Biotechnologies qualify as Biologics CDMOs. When choosing between them for Biologics programs, weigh these four dimensions specifically — each carries through to the side-by-side scorecard above.

Scale & bioreactor fit

Match validated bioreactor scale (from a few hundred litres clinical to 2,000L+ commercial) and single-use vs stainless to your dose and indication. Confirm titer expectations for your construct.

Cell line & process development

Ask whether the CDMO offers its own expression platform/cell line or works from yours, and how process development and tech transfer are handled.

Regulatory track record

Biologics programs heading to BLA/MAA need a strong commercial-scale inspection history. Cross-check FDA 483s, warning letters, and EMA/MHRA GMP coverage — all shown above.

Drug substance to drug product

Confirm whether the CDMO covers fill-finish and formulation in-house or coordinates a separate site, which affects timelines and comparability.

See all Biologics CDMOs ranked by Signal Score →

Frequently asked: Cytovance Biologics vs FUJIFILM Diosynth Biotechnologies

How does Cytovance Biologics compare to FUJIFILM Diosynth Biotechnologies for Biologics manufacturing?

On CDMO Signal's composite Signal Score, Cytovance Biologics is 79/100 and FUJIFILM Diosynth Biotechnologies is 85/100; Cytovance Biologics has 1 FDA inspection on record vs 0 for FUJIFILM Diosynth Biotechnologies; European coverage is 0 active EMA+MHRA certificates for Cytovance Biologics vs 35 for FUJIFILM Diosynth Biotechnologies. Both are tracked in the CDMO Signal directory as Biologics CDMOs. The scorecard above breaks down every metric side by side — use it alongside each CDMO's individual profile for the full regulatory and clinical footprint.

Which has the stronger FDA inspection record, Cytovance Biologics or FUJIFILM Diosynth Biotechnologies?

Both Cytovance Biologics and FUJIFILM Diosynth Biotechnologies maintain clean enforcement records on file — no FDA warning letters and no OAI classifications. Cytovance Biologics has 1 FDA inspection on record; FUJIFILM Diosynth Biotechnologies has 0.

How do Cytovance Biologics and FUJIFILM Diosynth Biotechnologies compare on European GMP coverage?

Cytovance Biologics holds 0 active EMA GMP certificates and 0 MHRA / UK certificates. FUJIFILM Diosynth Biotechnologies holds 29 active EMA GMP certificates and 6 MHRA / UK certificates. Use these counts as a proxy for the breadth of each CDMO's European regulatory footprint.

Which is better for Biologics manufacturing — Cytovance Biologics or FUJIFILM Diosynth Biotechnologies?

Both Cytovance Biologics and FUJIFILM Diosynth Biotechnologies are tagged as Biologics CDMOs in our directory, so both are credible options for Biologics programs. The most important differentiator for Biologics selection is typically scale & bioreactor fit: Match validated bioreactor scale (from a few hundred litres clinical to 2,000L+ commercial) and single-use vs stainless to your dose and indication. Confirm titer expectations for your construct. Review each CDMO's profile and inspection record before shortlisting.

What does the Signal Score gap mean in practice?

Cytovance Biologics carries a Signal Score of 79/100 and FUJIFILM Diosynth Biotechnologies carries 85/100 — a small lead for FUJIFILM Diosynth Biotechnologies. The Signal Score combines quality (FDA inspections + EMA/MHRA GMP), operational performance, financial stability, and capacity intelligence. CDMOs cannot pay to influence their score.

Evaluating Cytovance Biologics and FUJIFILM Diosynth Biotechnologies for a program?

Use the free AI matchmaker to weigh both against your specific requirements — capacity, modality, regulatory record, geography — and surface other qualified options.

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Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.